Technology & Devices

Macrogen and Exosome Plus to Jointly Develop Exosome-based Diagnostic and Treatment Solutions

SEOUL, South Korea–(BUSINESS WIRE)–The precision medicine and biotechnology company Macrogen (CEO Kap-Seok Yang, www.macrogen.com/en/) announced on April 24 that it had signed a supply contract with Exosome Plus (CEO Jong-Uk Bu, www.exosomeplus.com) on April 19 to become the exclusive buyer of the exosome isolation kits developed by Exosome Plus. The two companies also signed an MOU …

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FDA Permits Marketing of First Medical Device for Treatment of Attention Deficit Hyperactivity Disorder

The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication …

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Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC

SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has updated its approval of the company’s PD-L1 IHC 22C3 pharmDx assay. The assay can now be used as a companion diagnostic to identify a broader range of patients with stage III or metastatic …

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FDA Clears HemoSonics’ Quantra QPlus System, a Rapid Coagulation Diagnostic for Hospital Transfusion Management

Charlottesville, VA – March 13, 2019 – HemoSonics today announced that its innovative Quantra Hemostasis Analyzer platform, and its initial QPlus cartridge have been granted de novo marketing authorization by the FDA and are now available for sale in the United States. The fast and easy-to-use Quantra QPlus System provides novel and …

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Federal Agencies Charge 24 People in $1.2 Billion Medicare Telemedicine Fraud Scheme

One of the largest health care fraud schemes investigated by the FBI and the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) and prosecuted by the Department of Justice resulted in charges against 24 defendants, including the CEOs, COOs and others associated with five telemedicine …

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Foundation Medicine and Flatiron Publish Validation of Clinico-Genomic Database as a Platform to Advance Oncology Drug Development and Personalized Cancer Care

CAMBRIDGE, Mass. & NEW YORK–(BUSINESS WIRE)–Foundation Medicine and Flatiron Health today announced the publication of study results in the Journal of the American Medical Association validating that real-world clinico-genomic data obtained during the course of routine patient care can yield scientifically and clinically meaningful insights. These insights can serve as real-world evidence …

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Myriad, AstraZeneca and Merck Expand Companion Diagnostic Partnership in Prostate Cancer

SALT LAKE CITY, April 04, 2019 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized medicine, today announced that it has expanded its companion diagnostic collaboration with AstraZeneca and Merck (known as MSD outside the US and Canada).   Under the expanded collaboration, the companies will use BRACAnalysis CDx® to …

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Veracyte Announces Data Published in The Lancet Respiratory Medicine Demonstrate that the Envisia Genomic Classifier Improves Diagnosis of IPF

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. announced that data published online today in The Lancet Respiratory Medicine suggest that use of the company’s Envisia Genomic Classifier improves diagnosis for patients undergoing evaluation for interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF). The Envisia classifier is the first commercially available test that …

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Boehringer Ingelheim Enhances Oncology R&D with Novel MacroDel Delivery Technology Via Acquisition of ICD Therapeutics

INGELHEIM, Germany & BERLIN–(BUSINESS WIRE)–Boehringer Ingelheim today announced that it acquired ICD Therapeutics. The acquisition includes rights to ICD’s innovative MacroDel biologics-delivery platform. Boehringer Ingelheim will employ this platform for the development of novel therapeutics in collaboration with nanoPET Pharma GmbH, a former shareholder of ICD Therapeutics. Further details of …

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FDA Advances Landmark Policy Changes to Modernize Mammography Services and Improve their Quality

Today, the U.S. Food and Drug Administration announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. For the first time in more than 20 years of regulating mammography facilities, the agency is …

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